Adding belimumab to standard therapy for lupus nephritis (LN) is associated with better renal outcomes compared with standard therapy alone, according to data presented at the European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) 2020 virtual congress.
The data are from the 2-year BLISS-LN study, a randomized, double-blind, placebo-controlled trial that included 448 adult patients with active LN. Patients who received belimumab, a recombinant human monoclonal antibody approved for use in patients older than 5 years with active systemic lupus erythematosus, in addition to standard therapy were significantly more likely than those who received placebo plus standard therapy to have a primary efficacy renal response (PERR, 43% vs 32%) and a complete renal response (CRR, 30% vs 19.7%) at 2 years.
The investigators, led by Brad H. Rovin, MD, of Ohio State University in Columbus, defined PERR as a urine protein creatinine ratio (UPCR) of 0.7 or less, estimated glomerular filtration rate (eGFR) not exceeding 20% below pre-flare value or 60 mL/min/1.73 m2 or higher, and no treatment failure. They defined CRR as a UPCR below 0.5, an eGFR not more than 10% below pre-flare value or 90 mL/min/1.73 m2 or higher, and no treatment failure.
In the study, 118 patients received cyclophosphamide-based induction therapy followed by azathioprine maintenance of remission and 328 patients received mycophenolate mofetil (MMF) for both induction and maintenance of remission therapy. Overall, 224 patients received belimumab and 224 received placebo.
Overall, 28.3% of placebo recipients experienced a renal-related event or death compared with 15.7% of belimumab-treated patients. Belimumab-treated patients had a significant 49% lower risk of a renal-related event or death at any time point during the study compared with placebo recipients.
“MMF is already used in many patients. It has been shown to be equivalent to cyclophosphamide in the induction therapy of LN, and superior to azathioprine in the maintenance phase. Adding belimumab can further improve the treatment results,” Dr Rovin said in an ERA-EDTA press statement.
The safety profile for belimumab plus standard therapy was similar to that of standard therapy alone, according to Dr Rovin.
Rovin B, Houssiau FA, Furie R, et al. Efficacy and safety of belimumab in patients with active lupus nephritis: A phase 3, randomized, placebo-controlled trial. Presented at the European Renal Association-European Dialysis and Transplant Association 2020 virtual congress. LBCT 4544.